Nuron Biotech Completes Enrollment of a Pivotal Phase 3 Study for Proprietary Recombinant Human Interferon Beta-1b (NU100) in Relapsing Remitting Multiple Sclerosis
11/13/2012 9:29:15 AM
EXTON, Pa.--(BUSINESS WIRE)--Nuron Biotech Inc., a specialty biologics and vaccines company, today announced the completion of enrollment in its randomized, double-blind, placebo-controlled, parallel-group, pivotal Phase 3 study to evaluate the safety and efficacy of NU100 for the treatment of relapsing remitting multiple sclerosis (RRMS). This pivotal Phase 3 study is expected to be filed in support of the European marketing authorization application (MAA) in early 2014. NU100 is a proprietary recombinant human interferon beta-1b being developed as a new chemical entity. Produced utilizing an advanced processing technology, the liquid product formulation is virtually aggregate-free and human serum albumin-free (HSA-free), which may result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.